Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection

October 14, 2016 updated by: Xavier Valldeperas, Fundació Institut Germans Trias i Pujol
Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with diabetic macular edema

Description

Inclusion Criteria:

  • diabetic macular edema treatable with antiangiogenic drugs

Exclusion Criteria:

  • age under 18
  • cardiovascular events during the last year
  • previous vitrectomy
  • previous macular edema treatment during the last 4 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-PVD subjects
Patients with no PVD on SD-OCT at basal visit
Drug: Intravitreal Ranibizumab injection
PVD subjects
Patients with PVD on SD-OCT at basal visit
Drug: Intravitreal Ranibizumab injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in best-corrected visual acuity
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in central macular thickness
Time Frame: One year
One year
Number of ranibizumab injections
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFT-RAN-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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